164 recalls tagged with “workplace”.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Increased risk of purge leaks with Generation 1 purge cassettes.
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
Erbe USA recalled 5,154 Flexible Cryoprobes used in surgery after probes may rupture during activation. The defect can cause rupture or burst during activation. Stop using the device and follow recall instructions from the manufacturer.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
Reports of devices sparking/popping and potentially burning patients.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).